Cleared Traditional

CODMAN ETHISORB DURA PATCH

K991413 · Johnson & Johnson Professionals, Inc. · Neurology
Mar 2000
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K991413 is an FDA 510(k) clearance for the CODMAN ETHISORB DURA PATCH, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on March 13, 2000, 325 days after receiving the submission on April 23, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K991413 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1999
Decision Date March 13, 2000
Days to Decision 325 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXQ — Dura Substitute
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5910